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[FDA News] FDA Assembles Meeting to Address Concerns Over Pulse Oximeters' Accuracy in Darker-Skinned Individuals

Date: 2/12/2024

The Food and Drug Administration (FDA) recently convened a meeting to address growing concerns surrounding the accuracy of pulse oximeters, particularly in individuals with darker skin pigmentation. The meeting, held on Tuesday, aimed to examine mounting real-world evidence suggesting that these devices may not provide accurate readings for such individuals, potentially impacting patient care, particularly in hospital settings where timely interventions are crucial.

Pulse oximeters operate by shining light through a fingertip to analyze the amount of light that passes through, a process designed to detect low blood oxygen levels. However, past studies have indicated that the accuracy of pulse oximeters may be compromised in individuals with darker skin. During the meeting, the FDA reviewed a range of data sources, including published literature, Medical Device Reporting (MDR) data, and clinical evidence from studies, to better understand this issue.

The panel discussed various concerns related to pulse oximeter accuracy and proposed recommendations for healthcare providers, patient labeling, and study design and analyses. Notably, the panel acknowledged the challenges associated with retrospective studies on this topic, which often rely on self-reported race and ethnicity without directly assessing skin pigmentation.

Despite these limitations, the meeting's executive summary highlighted a growing body of real-world evidence suggesting that pulse oximeter accuracy may vary based on self-reported race and skin pigmentation. However, the panel emphasized the need for prospective studies incorporating standardized measurement of skin pigmentation and capturing simultaneous measurements of blood oxygen levels to obtain more robust evidence on the impact of skin pigmentation on pulse oximetry.

The FDA previously issued a Safety Recommendation, warning about factors that can affect pulse oximeter accuracy, including poor circulation, skin pigmentation, and other environmental factors. However, only a small percentage of pulse oximeter devices currently list dark pigmentation as a potential factor affecting accuracy on their labels.

Moving forward, the FDA aims to gather more data from studies integrating variability in skin pigmentation into their design. Despite challenges in assessing skin pigmentation for medical device development, the agency is funding two studies—one in adults and another in children and young adults—to provide prospective data on this issue. By designing studies to consider skin pigmentation from the outset, researchers hope to gain a better understanding of pulse oximeter accuracy and its implications for patient care.

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